Liver ResectionNCT06905041
Preoperative Anemia Affected to Postoperative Outcomes in Liver Resection
An observational study of Liver Resection and Anemia, run by Chiang Mai University.
Trial summary
To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Liver Resection, Anemia, Postoperative Mortality and Morbidity
- How many people
- 728 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent elective liver resection in setting hospital during January, 2006 to December, 2024
Who may be able to join
- All genders, age 20 to 75 years old who undergoing elective liver resection
- American Society of Anesthesiologists (ASA) physical status classification of I-III
Who cannot join
- Living donor liver resection
- Withdrawal criteria:
- Unresectable tumor
- Cardiac arrest during operation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Preoperative Anemia on Postoperative Outcomes in Liver Resection: A Propensity Score Matching Analysis
To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection
Read the detailed description
Globally, anemia affects approximately 33% of the population, with nearly 50% of cases attributed to iron deficiency. In Thailand, anemia remains a significant public health issue, with prevalence rates of 24% among women of reproductive age, 23.8% among nonpregnant women, and 32.2% among pregnant women. Iron deficiency anemia (IDA) is the leading and most common cause of anemia worldwide, and it is highly prevalent in Thailand. Moreover, the situation in Thailand is often exacerbated by the widespread incidence of thalassemia and hemoglobinopathies, with 30% to 40% of the population carrying thalassemia genes.
According to the World Health Organization (WHO), anemia is defined as a hemoglobin concentration of less than 12 g/dL in nonpregnant women and less than 13 g/dL in men. The prevalence of preoperative anemia among surgical patients has been reported to be between 32% and 48%. Preoperative anemia is one of the most common medical conditions encountered in surgical patients, with a prevalence ranging from 20% to 45% depending on the type of surgery. Specifically, in hepato-pancreato-biliary (HPB) surgery, 16.9% to 32.8% of patients present with anemia prior to surgery.
Preoperative anemia is a well-established predictor of the need for perioperative blood transfusions in liver resection, as supported by multiple studies. Perioperative allogeneic blood transfusions are associated with numerous adverse outcomes, both short-term and long-term. These include transfusion reactions, increased rates of postoperative infections, cardiopulmonary and thromboembolic events, prolonged mechanical ventilation, re-operations, extended hospital and ICU stays, elevated postoperative morbidity, increased tumor recurrence, reduced disease-specific survival, and decreased overall survival.
A large retrospective study reported a prevalence of preoperative anemia at 32.8%, which was associated with higher rates of postoperative major morbidities and mortality. After adjusting for confounding factors-such as age, type of liver resection, ASA classification, preoperative laboratory results, comorbidities, functional status, and diagnosis-patients with preoperative anemia were found to have a 21% higher risk of developing major morbidities within 30 days (adjusted odds ratio 1.21, 1.09-1.33). These morbidities included organ space infections, sepsis, septic shock, prolonged postoperative ventilator use (>48 hours), unplanned reintubation, pneumonia, and acute kidney injury requiring dialysis. However, preoperative anemia was not associated with increased postoperative mortality in liver resection (adjusted odds ratio 0.88, 0.66-1.16).
Furthermore, a retrospective study involving 4,170 patients demonstrated that preoperative anemia was associated with an increased risk of major postoperative complications compared to patients without anemia (24% versus 19%). After adjusting for confounders, including age, sex, race, obesity, extent of liver resection, comorbidities, functional status, and clinical and biochemical markers of liver dysfunction and portal hypertension, preoperative anemia was linked to a threefold increased risk of blood transfusion, a twofold increased risk of prolonged hospitalization, and higher healthcare costs in anemic patients. These findings suggest that anemia significantly impacts resource utilization in liver resection.
In a broader context, a study involving 227,425 patients from the ACS-NSQIP database who underwent major non-cardiac surgery reported that 30.4% of patients had preoperative anemia. The results showed that preoperative anemia was associated with increased morbidity and mortality within 30 days, even after adjusting for several known risk factors, including transfusions. Despite this evidence, there are limited studies specifically evaluating the impact of preoperative anemia on outcomes in specific surgeries, particularly liver resection.
The findings of this study could enhance physicians' understanding of the impact of preoperative anemia on postoperative outcomes, emphasizing the importance of its evaluation and treatment. Therefore, the assessment and management of preoperative anemia are essential components of patient blood management in liver resection. Proper assessment and timely intervention could mitigate associated risks and improve surgical outcomes.
- Keywords
- Preoperative anemia, liver resection, posteoperative complication
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anemia group | The patients who had preoperative anemia (hemoglobin levels < 12 g/dL in female and < 13 g/dL in male) before liver resection | |
| No anemia group | The patients who did not have preoperative anemia before liver resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 30-day morbidity rate
- To determine whether preoperative anemia is associated with increased risk of postoperative 30-day morbidity in patients undergoing liver resection.
Measured: From enrollment to the postoperative day 30
Secondary outcomes (1)
Allogenic blood transfusion, comprehensive complication index, postoperative outcomes, and mortality rate
- To determine the incidence of preoperative anemia in liver resection patients.
- To determine the incidence of postoperative 30-day morbidities rate
- To evaluated the postoperative 30-day morbidities rate, classified using:
- Clavien Dindo classification
- Comprehensive complication index (CCI)
- To determine postoperative major complication, defined as Clavien-Dindo classification grade III or higher or CCI > 40
- To assess the length of hospital stay
- To assess the length of ICU stay and ventilator day
- To evaluate postoperative 30-day mortality
Measured: From enrollment to the postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warangkana Lapisatepun, Chiang Mai University
- Investigators
- Warangkana Lapisatepun, MD. PhD., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905041
- Sponsor's protocol ID
- ANE-2568-0141
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Anemia on Postoperative Outcomes in Liver Resection: A Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06905041
- Acronym / sponsor ID
- ANE-2568-0141
- Keywords
- Preoperative anemia, liver resection, posteoperative complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection
Detailed description
Globally, anemia affects approximately 33% of the population, with nearly 50% of cases attributed to iron deficiency. In Thailand, anemia remains a significant public health issue, with prevalence rates of 24% among women of reproductive age, 23.8% among nonpregnant women, and 32.2% among pregnant women. Iron deficiency anemia (IDA) is the leading and most common cause of anemia worldwide, and it is highly prevalent in Thailand. Moreover, the situation in Thailand is often exacerbated by the widespread incidence of thalassemia and hemoglobinopathies, with 30% to 40% of the population carrying thalassemia genes.
According to the World Health Organization (WHO), anemia is defined as a hemoglobin concentration of less than 12 g/dL in nonpregnant women and less than 13 g/dL in men. The prevalence of preoperative anemia among surgical patients has been reported to be between 32% and 48%. Preoperative anemia is one of the most common medical conditions encountered in surgical patients, with a prevalence ranging from 20% to 45% depending on the type of surgery. Specifically, in hepato-pancreato-biliary (HPB) surgery, 16.9% to 32.8% of patients present with anemia prior to surgery.
Preoperative anemia is a well-established predictor of the need for perioperative blood transfusions in liver resection, as supported by multiple studies. Perioperative allogeneic blood transfusions are associated with numerous adverse outcomes, both short-term and long-term. These include transfusion reactions, increased rates of postoperative infections, cardiopulmonary and thromboembolic events, prolonged mechanical ventilation, re-operations, extended hospital and ICU stays, elevated postoperative morbidity, increased tumor recurrence, reduced disease-specific survival, and decreased overall survival.
A large retrospective study reported a prevalence of preoperative anemia at 32.8%, which was associated with higher rates of postoperative major morbidities and mortality. After adjusting for confounding factors-such as age, type of liver resection, ASA classification, preoperative laboratory results, comorbidities, functional status, and diagnosis-patients with preoperative anemia were found to have a 21% higher risk of developing major morbidities within 30 days (adjusted odds ratio 1.21, 1.09-1.33). These morbidities included organ space infections, sepsis, septic shock, prolonged postoperative ventilator use (>48 hours), unplanned reintubation, pneumonia, and acute kidney injury requiring dialysis. However, preoperative anemia was not associated with increased postoperative mortality in liver resection (adjusted odds ratio 0.88, 0.66-1.16).
Furthermore, a retrospective study involving 4,170 patients demonstrated that preoperative anemia was associated with an increased risk of major postoperative complications compared to patients without anemia (24% versus 19%). After adjusting for confounders, including age, sex, race, obesity, extent of liver resection, comorbidities, functional status, and clinical and biochemical markers of liver dysfunction and portal hypertension, preoperative anemia was linked to a threefold increased risk of blood transfusion, a twofold increased risk of prolonged hospitalization, and higher healthcare costs in anemic patients. These findings suggest that anemia significantly impacts resource utilization in liver resection.
In a broader context, a study involving 227,425 patients from the ACS-NSQIP database who underwent major non-cardiac surgery reported that 30.4% of patients had preoperative anemia. The results showed that preoperative anemia was associated with increased morbidity and mortality within 30 days, even after adjusting for several known risk factors, including transfusions. Despite this evidence, there are limited studies specifically evaluating the impact of preoperative anemia on outcomes in specific surgeries, particularly liver resection.
The findings of this study could enhance physicians' understanding of the impact of preoperative anemia on postoperative outcomes, emphasizing the importance of its evaluation and treatment. Therefore, the assessment and management of preoperative anemia are essential components of patient blood management in liver resection. Proper assessment and timely intervention could mitigate associated risks and improve surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemia group | – | –The patients who had preoperative anemia (hemoglobin levels < 12 g/dL in female and < 13 g/dL in male) before liver resection |
| No anemia group | – | –The patients who did not have preoperative anemia before liver resection. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective liver resection in setting hospital during January, 2006 to December, 2024
Key inclusion criteria (2 listed)
- All genders, age 20 to 75 years old who undergoing elective liver resection
- American Society of Anesthesiologists (ASA) physical status classification of I-III
Key exclusion criteria (4 listed)
- Living donor liver resection
- Unresectable tumor
- Cardiac arrest during operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative 30-day morbidity rate
Time frame: From enrollment to the postoperative day 30
• To determine whether preoperative anemia is associated with increased risk of postoperative 30-day morbidity in patients undergoing liver resection.
1 secondary outcome
Allogenic blood transfusion, comprehensive complication index, postoperative outcomes, and mortality rate
Time frame: From enrollment to the postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Warangkana Lapisatepun, MD. PhD. principal investigator
Chiang Mai University
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Resection and Anemia, run by Chiang Mai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warangkana Lapisatepun, MD. PhD. (+66910688716, warangkana.c@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 30-day morbidity rate (time frame: From enrollment to the postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.